Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

Study Overview

• Status: Completed
• Conditions: Polyp of Large Intestine
• Intervention / Treatment: Procedure: removal of eligible polyps using cold snare polypectomy technique; Procedure: removal of eligible polyps using double biopsy technique

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 130-702
    • Kyunghee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over the age of 20
• Informed consent

Exclusion Criteria:

• Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
• Known existing bleeding tendency (thrombocytopenia or prolonged INR)
• Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
• ASA class III or more
• Pregnancy
• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold snare polypectomy	Procedure: removal of eligible polyps using cold snare polypectomy technique; Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
Experimental: Double biopsy polypectomy	Procedure: removal of eligible polyps using double biopsy technique; Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete histologic polyp eradication rate	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken for polypectomy (complete visual eradication of each polyp)	time from polyp resection to tissue retrieval	2 weeks
Successful tissue retrieval rate of removed tissues		2 weeks
Rates of adverse events	Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).	4 weeks
Complete visual polyp eradication rate		2 weeks

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Investigators: Principal Investigator: Chang Kyun Lee, MD, PhD, Kyung Hee University Hospital

Publications and helpful links

General Publications

• Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.
• Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16.
• Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
• Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: CPP2012